Regulatory Affairs Update Philippines

Philippines: FDA Released Draft Regulation on the Guideline Prescribing the Rules, Requirements and Procedures in the Application for LTO of Covered Health Product Establishments

To further develop the Philippines Food and Drug Administration’s (FDA) processes and automation of their system for initial, renewal and variation applications for the License to Operate (LTO) through the FDA eServices Portal System, the FDA proposed revisions on the documentary and other technical requirements for LTO applications to be abreast with internationally acceptable standards. In line with this, FDA released a draft regulation entitled, “Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017”.

In this draft, the FDA has provided comprehensive requirements to promote transparency with the local establishments to be covered by this Administrative Order. Also, in this issuance, the FDA has provided the step-by-step application procedure as well as their respective requirements, extension of the validity of the LTO depending on the establishments’ business profiles, and the grounds for the suspension and/or cancellation and revocation.

You can view the details on the links below:

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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